Document M4xdJwXaKgZBLe9mnzxe4NXbL
FILE NAME Talc TALC DATE 1971 Aug
DOC TALC148
DOCUMENT DESCRIPTION Memo RE FDA Meeting - Asbestos in
Cosmetic Talcs
Paeerees
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Research & |EngineeringCenter
August 1971 ne :
The
purpose and
listof
participants
anddiscussants discusants
in the attached two handouts from the meeting
Resources angdiory: Romer NYCDepartment of Air
set the basis
FDA * :
meeting
meeting
andreiterated
his
demands
that
the
+
sk
tg
tales
evaluatceosmetiocy
tales
acceptable
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August ;
11 1971
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Mapelerada
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: FDA MEETING a pings
,
Mapelrad
ASBESTOS IN COSMETIC TALCS
bra
+
relatively Vermont talcsi sourceof J generally ;
tr"- free of
s
:
: ongter
molite or other minerals davaakie?
asbestos Health Safety tay
Dr. Lewis J
National Institute ofOccupational -:
bar el
Cincinnati ae
2
=
oR or
ok. Safety
and
Ohio
cpt
be
pee
lt
eae
pape
I'D
talcby X
. tos fiber
Ex.6068-2 WINKELTRSCPT00001497
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August 1971
wel
3 wean Page %
COSMETIC 3, wow - FDA MEETING MEETING ASABSBESETOSSTOS IN
att
|
previously Dr. experiments used phy- -
animal
experiments withtalc
on
Described A sicians gloves injected
into bellies of animals
intentionally intertracheal These produced no granulomas granulomas describeddescribed intertracheal
in low
types three jections of hamsters with
of talc talc high nickel
nickel and off the shelf cosmetic talc Nofibrosis after 2
Webster's two years despite excessive amounts amountsused He noted Ian
long least conclusions
harmful that ?
fibers must be at
5 microns
to be
hie
ae
Webster's ST
Pe
studying health in
interest Selikoff
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August 11 1971
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TALCS
:
ASBESTOS jINCOSMETICTALCS
:
:
x
injectable subject of asbestos in
drugs and stated more
thanhalfof injectable injectable drugs ina survey -at the Mt. Sinai
Pharmacy a Hospital
in amounts
+
oF
gramin a vial res a
at
-
po. ia ~ i
Ss
man S. Speil -
Bae
- Manvilletechnology
Sembee
Reviewedasbestos technology and
the
importance
of
into
respirable
Mor
fraction
sample
separation
andes
total ogee
&
ynet
sae
ca
AM weak
Ni
IgG
nce
Ex.6068-4 WINKELTRSCPT00001499
August
August
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1971
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August Ss 11 1971
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FDA MEETING ASBESTOS EN
COSMETIC
TALCS
COSMETCIOCSMETIC COSMETIC TALCS .
:
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plete evaluation fibaeprpsroximately week for RATED By slides by one work presence me : le
a
yhqie
identification diffraction chry- electron of by a _
per sotile shape cent chee "
evaluation
by
oom
ae
-
a
a
one week week
sample
Showed many
.
fibers
EM and chrysofile not
com- CR indi-
verified verified
aa
Still feels identification
SWE
to 95
certain certain
Se
ies
ean
,
ttn
Aan.
set
slight impurity
petrographic chemical Angstroms petrographic
that 8.4
"
amphibole analysisand
ray plus serpentine centweresensitive
for
detectors 2detectors
mately 0.50.5percent
Sor
tS
Dr. Wilson
Nashed
of
group representing
Ex.6068-5
WINKELTRSCPT00001500
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August ?
11 1971
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Page 67
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A
METING FDA MEETING COSMETIC ASBESTOS IN
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TALCS
TALCS -
tA
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wns a
Hydromagnesite is eat, Diameter fibrous 2
is
in form .
of 200 Angstroms
Hydromagnesite with a hole down the center *
is known fo.
occur
in
some
talc deposits Geiger Geiger questions
of
some ofThis
This
Art Langer's identification chrysotile fibrils
.
University University was smoke screen but a good counter offensive }to LangLaneger r
finding chrysotile everywhere
4
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Fd
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Pooley Dr. E. Di
-
4
of South Wales oR
liquid techniques diffraction by ExaminedJ talc
EM
- sity separation in a centrifuge
identified talc by electron
including heavy
den-
All fibrous constituentsconstituents were coe gs
as
CP
t
=beautiful ne
electron Showed beautiful
.
hy
2 wae
micrographs
talc
using goldplatelets . plating
Samples were madeind by replication
plating x
areye cates
ew
i
'
atte
F. Nicphroolpsoosned Mt. Sinai we lowlevel Dr. W.
Dr. Sales pitch
technique for surveying
- Mt.
8 low
a cosmetic talcs .
and
The lowlevel
would et
lecvehl rysotile light material was include polarizedlight
microscopy microscopy and X ray
examination and
then possibly electron electronmicroscopy plus identification
identification
:
slaarrfyo|r| Lmacnoguelrdqquueessttiioonnss
whether Ipercent detectedshowed
studies
in fibril- *
Spex milled +
chrysotile chrysotile with not pattern visible
visible
longer
aaffter ter
intensive grinding
material no longer
Nicholson'sNicholson's* more
samples initialsurvey
. air
1. airsampling
tests and complete analysis from
gamutof samples |after preliminarpyreliminary screening
c
2 statistical study of theMt. - Sinai lung survey
of
0
New York people people
tocorrelate
fiber and
talc
in
content
the
jh
. j lungs with with talc usage ^/nd
| dumeyrs
+
tehnat
Se
Ex.6068-6 WINKELTRSCPT00001501
Rot ses tony RT Bt Leas
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san : i August 11 1971
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MEETING ' COSMETIC TALCS ASBESTOS IN COSMETIC TALCS rr Se a complete epidemiological epidemiological
+" producing.cosmetic producing.cosmetic talts
a
i
.
a
study of the workers . the
ot
mining and
~y
7
:
S
.
;
C. Maggiore- Mt. Sinai School of Medicine
Sinai
Reported on Mt. Sinai exploratory work towards
the of of instrumentation for completely characterizing
development
and
fibers and particleisn sample shape
size
many
all
chemical
analysis etc.
3
He indicated the need for approximately 300,000
years and to
for design and construction ofa prototype unit
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